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What's in Store for Orchard Therapeutics (ORTX) Q4 Earnings?
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We expect Orchard Therapeutics plc to beat expectations when it reports fourth-quarter and full-year 2020 results. The company should provide updates on the launch activities of Libmeldy (OTL-200) in Europe.
Shares of the company have slumped 28% in the past year against with the industry’s growth of 14.9%.
In the last reported quarter, it delivered an earnings surprise of 54.55%. Moreover, Orchard delivered an average positive earnings surprise of 9.09% in the trailing four quarters.
Let’s see how things have shaped up prior to the upcoming results.
Factors Likely to Impact Q4 Results
Revenues from product salesof Strimvelis, approved to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID),increased slightly in the third quarter of 2020. We expect the trend to have continued in the fourth quarter.
In December 2020, the European Commission (EC) granted full market authorization toOTL-200,a lentiviral vector-based gene therapy approved for the treatment of eligiblemetachromatic leukodystrophy (MLD) patients. OTL-200 will be marketed under the brand name —Libmeldy. We expect the company to provide updates on the launchplansof Libmeldy in the fourth quarter.
In November 2020, the FDA cleared the company’s investigational new drug (IND) application for OTL-200.In January 2021, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to OTL-200. The designation provides an opportunity for increased interactions with the FDA to determine the optimal path to submit a biologics license application (BLA) for OTL-200 in the United States. We expect the company to provide updates on the same in the fourth quarter.
We expect updates on the company’s pipeline products —OTL-201, OTL-103 and OTL-203.
In December 2020, Orchard reported initial data from an ongoing proof-of-concept study evaluating the safety and efficacy of OTL-201, an investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy being studied for the treatment of mucopolysaccharidosis type IIIA (MPS-IIIA). The data showed encouraging progress for patients and families living with MPS-IIIA, a progressive, life-threatening metabolic disease with no approved treatment options.
The company is evaluating OTL-203, an investigational ex vivo autologous HSC gene therapy in development for the treatment of mucopolysaccharidosis type I (MPS-I). The company expects to initiate a registrational study on the candidate in 2021.
The company is also evaluating OTL-103, which is in clinical development for the treatment of Wiskott-Aldrich syndrome (WAS). WAS is a rare disease with immunological deficiency and reduced ability to form blood clots. The company expects to submita BLA and an EU marketing authorization application (MAA) in 2021 for the candidate.
What Our Model Indicates
Our proven model predicts an earnings beat for Orchard in the soon-to-be-reported quarter asit has the right combination of the two key ingredients. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings surprise.
Earnings ESP: Orchard’s Earnings ESP is + 25.00% as the Most Accurate Estimate of a loss of 23 cents is narrower than the Zacks Consensus Estimate of a loss of 30 cents. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Here are some biotech stocks with the right mix of elements to beat on earnings this time around:
Castle Biosciences Inc. (CSTL - Free Report) has an Earnings ESP of +31.82 % and a Zacks Rank #3.
Immunovant Inc. (IMVT - Free Report) has an Earnings ESP of +4.55 % and a Zacks Rank #2.
Atea Pharmaceuticals Inc. (AVIR - Free Report) has an Earnings ESP of +279.59% and a Zacks Rank #2.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana. Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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What's in Store for Orchard Therapeutics (ORTX) Q4 Earnings?
We expect Orchard Therapeutics plc to beat expectations when it reports fourth-quarter and full-year 2020 results. The company should provide updates on the launch activities of Libmeldy (OTL-200) in Europe.
Shares of the company have slumped 28% in the past year against with the industry’s growth of 14.9%.
In the last reported quarter, it delivered an earnings surprise of 54.55%. Moreover, Orchard delivered an average positive earnings surprise of 9.09% in the trailing four quarters.
Let’s see how things have shaped up prior to the upcoming results.
Factors Likely to Impact Q4 Results
Revenues from product salesof Strimvelis, approved to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID),increased slightly in the third quarter of 2020. We expect the trend to have continued in the fourth quarter.
In December 2020, the European Commission (EC) granted full market authorization toOTL-200,a lentiviral vector-based gene therapy approved for the treatment of eligiblemetachromatic leukodystrophy (MLD) patients. OTL-200 will be marketed under the brand name —Libmeldy. We expect the company to provide updates on the launchplansof Libmeldy in the fourth quarter.
In November 2020, the FDA cleared the company’s investigational new drug (IND) application for OTL-200.In January 2021, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to OTL-200. The designation provides an opportunity for increased interactions with the FDA to determine the optimal path to submit a biologics license application (BLA) for OTL-200 in the United States. We expect the company to provide updates on the same in the fourth quarter.
We expect updates on the company’s pipeline products —OTL-201, OTL-103 and OTL-203.
In December 2020, Orchard reported initial data from an ongoing proof-of-concept study evaluating the safety and efficacy of OTL-201, an investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy being studied for the treatment of mucopolysaccharidosis type IIIA (MPS-IIIA). The data showed encouraging progress for patients and families living with MPS-IIIA, a progressive, life-threatening metabolic disease with no approved treatment options.
The company is evaluating OTL-203, an investigational ex vivo autologous HSC gene therapy in development for the treatment of mucopolysaccharidosis type I (MPS-I). The company expects to initiate a registrational study on the candidate in 2021.
The company is also evaluating OTL-103, which is in clinical development for the treatment of Wiskott-Aldrich syndrome (WAS). WAS is a rare disease with immunological deficiency and reduced ability to form blood clots.
The company expects to submita BLA and an EU marketing authorization application (MAA) in 2021 for the candidate.
What Our Model Indicates
Our proven model predicts an earnings beat for Orchard in the soon-to-be-reported quarter asit has the right combination of the two key ingredients. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings surprise.
Earnings ESP: Orchard’s Earnings ESP is + 25.00% as the Most Accurate Estimate of a loss of 23 cents is narrower than the Zacks Consensus Estimate of a loss of 30 cents. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Orchard has a Zacks Rank #3. You can see the complete list of today’s Zacks #1 Rank stocks here.
Orchard Therapeutics PLC Sponsored ADR Price and Consensus
Orchard Therapeutics PLC Sponsored ADR price-consensus-chart | Orchard Therapeutics PLC Sponsored ADR Quote
Stocks That Warrant a Look
Here are some biotech stocks with the right mix of elements to beat on earnings this time around:
Castle Biosciences Inc. (CSTL - Free Report) has an Earnings ESP of +31.82 % and a Zacks Rank #3.
Immunovant Inc. (IMVT - Free Report) has an Earnings ESP of +4.55 % and a Zacks Rank #2.
Atea Pharmaceuticals Inc. (AVIR - Free Report) has an Earnings ESP of +279.59% and a Zacks Rank #2.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana. Ignited by referendums and legislation, this industry is expected to blast from an already robust $17.7 billion in 2019 to a staggering $73.6 billion by 2027. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot stocks we're targeting >>